Senior Trial Manager

United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotech, Healthcare, PharmaceuticalsIndustries

Requirements

Candidates must possess over 6 years of experience managing and coordinating clinical trials in a project management or clinical operations role. A strong understanding of Good Clinical Practice/ICH guidelines, regulatory requirements, the drug development process, and clinical monitoring procedures is essential. Experience in leading and line-managing a team, managing study start-up and closeout, handling EC/IRB applications, and utilizing various clinical trial software are required. Experience with multi-site and IND/CTIMP trials is necessary, with previous startup/biotech experience being a plus.

Responsibilities

The Senior Trial Manager will lead and oversee CTIMP and non-CTIMP clinical trial programs, ensuring successful delivery on time, within budget, and to high quality standards. They will serve as the primary point of contact for sponsors, manage project partners' activities, and proactively identify and mitigate risks. Responsibilities include maintaining project information, tracking progress, ensuring inspection readiness, and directing project support staff. The role also involves managing a clinical operations team, facilitating training, and collaborating with tech, product, and quality management teams to enhance trial technology and processes.

Skills

Good Clinical Practice

ICH guidelines

regulatory requirements

drug development process

clinical monitoring procedures

clinical trial management

project management

clinical operations

team leadership

line management

study start-up

study closeout

EC/IRB applications

clinical trial software

multi-site trials

IND trials

CTIMP trials

Lindus Health

Accelerates clinical trials for life sciences

About Lindus Health

Lindus Health focuses on speeding up clinical trials to help patients access new treatments more quickly. The company operates differently from traditional contract research organizations (CROs) by using a fixed-price model for studies and milestone-based payments, which aligns their incentives with those of their clients. Lindus Health combines a skilled clinical operations team with a specialized software platform and access to a vast database of 30 million Electronic Health Records. They handle all aspects of clinical studies, including designing the study, recruiting patients, capturing clinical data, monitoring progress, and managing projects. With their approach, Lindus Health has successfully assisted over 90 sponsors in conducting clinical trials across the US, UK, and Europe, completing them up to three times faster than conventional CROs and often delivering results ahead of schedule.

London, United KingdomHeadquarters

2021Year Founded

$23MTotal Funding

SERIES_ACompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Flexible Work Hours

Mental Health Support

Enhanced Parental Leave

Professional Development Budget

Cycle to work scheme

Stock Options

Regular team events

A new laptop as your main workstation

Risks

AI-driven diagnostics could challenge Lindus Health's market position in clinical trials.

Rapid pathogen evolution in infectious disease trials requires continuous adaptation and innovation.

Demand for diverse patient populations may strain recruitment capabilities in less diverse regions.

Differentiation

Lindus Health accelerates trials using a unique software platform and 30 million EHRs.

They offer fixed-priced quotes and milestone-based payments, aligning incentives with clients.

Their 'All-in-One CRO' solutions cater to specific therapeutic areas like cardiovascular and infectious diseases.

Upsides

Decentralized trials align with Lindus Health's patient-centric approach, enhancing participant reach.

AI integration in trials complements their goal of accelerating clinical trial timelines.

Wearable technology in trials supports continuous monitoring, beneficial for cardiovascular studies.

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